Thiamethoxam; Pesticide Tolerances, 12731-12740 [2012-4983]

Download as PDF
12731
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations
rmajette on DSK2TPTVN1PROD with PROPOSALS
the free form of its acide metabolite CG–
321113 [(E,E)-(methoxyimino)-[2-[1-(3(trifluoromethylphenyl)ethylideneaminooxymethyl]phenyl]acetic acid, in or on imported
coffee, green bean at 0.02 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
VerDate Mar<15>2010
15:16 Mar 01, 2012
Jkt 226001
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 17, 2012.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Parts per
million
Commodity
*
*
*
*
*
*
*
*
*
*
are no U.S. registrations as of January 18, 2012 for use on coffee, green bean.
*
*
*
*
*
2 There
[FR Doc. 2012–4977 Filed 3–1–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–1079; FRL–9331–8]
Thiamethoxam; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of thiamethoxam
in or on multiple commodities which
are identified and discussed later in this
document. Syngenta Crop Protection,
Inc. requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective
March 2, 2012. Objections and requests
for hearings must be received on or
before May 1, 2012, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2010–1079. All documents in the
docket are listed in the docket index
Therefore, 40 CFR chapter I is
available at http://www.regulations.gov.
amended as follows:
Although listed in the index, some
PART 180—[AMENDED]
information is not publicly available,
e.g., Confidential Business Information
■ 1. The authority citation for part 180
(CBI) or other information whose
continues to read as follows:
disclosure is restricted by statute.
Authority: 21 U.S.C. 321(q), 346a and 371.
Certain other material, such as
copyrighted material, is not placed on
■ 2. Section 180.555 is amended by
the Internet and will be publicly
alphabetically adding the following
available only in hard copy form.
commodity and footnote 2 to the table
Publicly available docket materials are
in paragraph (a) to read as follows:
available in the electronic docket at
§ 180.555 Trifloxystrobin; tolerances for
http://www.regulations.gov, or, if only
residues.
available in hard copy, at the OPP
(a) * * *
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
Parts per
2777 S. Crystal Dr., Arlington, VA. The
Commodity
million
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
*
*
*
*
*
Coffee, green bean 2 .................
0.02 Facility telephone number is (703) 305–
5805.
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
ADDRESSES:
E:\FR\FM\02MRR1.SGM
02MRR1
12732
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations
FOR FURTHER INFORMATION CONTACT:
Gene Benbow, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 347–0235; email address:
Benbow.Gene@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at http://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
rmajette on DSK2TPTVN1PROD with PROPOSALS
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2010–1079 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
VerDate Mar<15>2010
15:16 Mar 01, 2012
Jkt 226001
received by the Hearing Clerk on or
before May 1, 2012. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2010–1079, by one of
the following methods:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of August 26,
2011 (76 FR 53372) (FRL–8884–9), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 0F7805) by
Syngenta Crop Protection, Inc., P.O. Box
18300, Greensboro, NC 27419. The
petition requested that 40 CFR 180.565
be amended by establishing tolerances
for residues of the insecticide
thiamethoxam, 3-[(2-chloro-5thiazolyl)methyl]tetrahydro-5-methyl-Nnitro-4H-1,3,5-oxadiazin-4-imine and its
metabolite, N-[(2-chloro-thiazol-5yl)methyl]-N’-methyl-N’’-nitroguanidine], in or on: buckwheat, grain at
0.02 per million (ppm); buckwheat,
forage at 0.50 ppm; buckwheat, hay at
0.02 ppm; buckwheat, straw at 0.02
ppm; oat, grain at 0.02 ppm; oat, forage
at 0.50 ppm, oat, hay at 0.02 ppm; oat,
straw at 0.02 ppm; millet, pearl, grain at
0.02 ppm; millet, pearl, forage at 0.02
ppm; millet, pearl, stover at 0.02 ppm;
millet, proso, grain at 0.02 ppm; millet,
proso, forage at 0.02 ppm; millet, proso,
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
stover at 0.02 ppm; millet, proso, straw
at 0.02 ppm; rye, grain at 0.02 ppm; rye,
forage at 0.50 ppm; rye, straw at 0.02
ppm; teosinte, grain at 0.02 ppm;
teosinte, forage at 0.10 ppm; teosinte,
stover at 0.05 ppm; triticale, grain at
0.02 ppm; triticale, forage at 0.05 ppm;
triticale, hay at 0.02 ppm; triticale, straw
at 0.02 ppm; wild rice, grain at 0.02
ppm. That notice referenced a summary
of the petition prepared by Syngenta
Crop Protection, Inc., the registrant,
which is available in the docket,
http://www.regulations.gov. There were
no comments received in response to
the notice of filing.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue * * *.’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for thiamethoxam
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with thiamethoxam follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
E:\FR\FM\02MRR1.SGM
02MRR1
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations
Thiamethoxam shows toxicological
effects primarily in the liver, kidney,
testes, and hematopoietic system. In
addition, developmental neurological
effects were observed in rats. This
developmental effect is being used to
assess risks associated with acute
exposures to thiamethoxam, and the
liver and testicular effects are the basis
for assessing longer term exposures.
Although thiamethoxam causes liver
tumors in mice, the Agency has
classified thiamethoxam as ‘‘not likely
to be carcinogenic to humans’’ based on
convincing evidence that a nongenotoxic mode of action for liver
tumors was established in the mouse
and that the carcinogenic effects are a
result of a mode of action dependent on
sufficient amounts of a hepatotoxic
metabolite produced persistently. The
non-cancer (chronic) assessment is
sufficiently protective of the key events
(perturbation of liver metabolism,
hepatotoxicity/regenerative
proliferation) in the animal mode of
action for cancer.
Specific information on the studies
received and the nature of the adverse
effects caused by thiamethoxam as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at http://
www.regulations.gov in section 4.5.1 in
the document ‘‘Thiamethoxam—Human
Health Risk Assessement for Crop
Group 15 (including buckwheat, pearl
millet, proso millet, oats, rye, teosinte,
triticale) and Crop Group 16
Commodities (forage, fodder and straw
of cereal grains group)’’ in docket ID
number EPA–HQ–OPP–2010–1079 at
http://www.regulations.gov.
Thiamethoxam produces a metabolite
known as CGA–322704 (referred to in
the remainder of this rule as
clothianidin). Clothianidin is also
registered as a pesticide. While some of
the toxic effects observed following
testing with thiamethoxam and
clothianidin are similar, the available
information indicates that
thiamethoxam and clothianidin have
different toxicological effects in
mammals and should be assessed
separately. A separate risk assessment of
clothianidin has been completed in
conjunction with the registration of
clothianidin. The most recent
assessment, which provides details
regarding the toxicology of clothianidin,
is available in the docket EPA–HQ–
OPP–2008–0945, at http://
www.regulations.gov. Refer to the
document ‘‘Clothianidin: Human Health
Risk Assessment for the Requested New
Use on Mustard Seen as well as New
Uses of Thiamethoxam on Peanuts,
Alfalfa, in Food-Handling
Establishments, and as a Seed
Treatment for Cereal Grains.’’
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
12733
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors (U/S F) are used in
conjunction with the POD to calculate a
safe exposure level—generally referred
to as a population-adjusted dose (PAD)
or a reference dose (RfD)—and a safe
margin of exposure (MOE). For nonthreshold risks, the Agency assumes
that any amount of exposure will lead
to some degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see http://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
A summary of the toxicological
endpoints for thiamethoxam used for
human risk assessment is shown in
Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIAMETHOXAM FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Acute dietary (All populations including infants and children).
Chronic dietary (All populations including infants and children).
rmajette on DSK2TPTVN1PROD with PROPOSALS
Incidental oral (all durations).
VerDate Mar<15>2010
Point of departure and
uncertainty/safety
factors
RfD, PAD, LOC for risk
assessment
Study and toxicological effects
NOAEL = 34.5 mg/kg/
day
UFA = 10x
UFH = 10x
FQPA SF = 1
NOAEL = 1.2 mg/kg/
day
UFA = 10x
UFH = 10x
FQPA SF = 1
Acute RfD = 0.35 mg/
kg/day.
aPAD = 0.35 mg/kg/day
Rat Developmental Neurotoxicity study.
LOAEL = 298.7 mg/kg/day based on delayed sexual maturation
in male pups, and reduced brain morphometric measurements.
Chronic RfD = 0.012
mg/kg/day.
cPAD = 0.012 mg/kg/
day.
NOAEL = 8.23 mg/kg/
day
UFA = 10x
UFH = 10x
FQPA SF = 1
MOE = 100 (residential)
2-Generation reproduction study.
1. LOAEL = 1.8 mg/kg/day based on increased incidence and
severity of tubular atrophy in testes of F1 generation males.
2-Generation reproduction study.
2. LOAEL = 3 (males), not determined (females) mg/kg/day
based on sperm abnormalities in F1 males.
90-day Dog study.
LOAEL = 32 (males) 33.9 (females) mg/kg/day based on slightly
prolonged prothrombin times and decreased plasma albumin
and A/G ratio (both sexes); decreased calcium levels and
ovary weights and delayed maturation in the ovaries (females); decreased cholesterol and phospholipid levels, testis
weights, spermatogenesis, and spermatic giant cells in testes
(males).
15:16 Mar 01, 2012
Jkt 226001
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
E:\FR\FM\02MRR1.SGM
02MRR1
12734
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIAMETHOXAM FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Point of departure and
uncertainty/safety
factors
RfD, PAD, LOC for risk
assessment
Study and toxicological effects
Oral study NOAEL =
1.2 mg/kg/day (dermal absorption rate =
5%)
UFA = 10x
UFH = 10x
FQPA SF = 1
Dermal study NOAEL =
60 mg/kg/day
UFA = 10x
UFH = 10x
FQPA SF = 1
Oral study NOAEL =
1.2 mg/kg/day (inhalation absorption rate
= 100% of oral absorption)
UFA = 10x
UFH = 10x
FQPA SF = 1
MOE = 100 (residential)
2-Generation reproduction study.
LOAEL = 1.8 mg/kg/day based on increased incidence and severity of tubular atrophy in testes of F1 generation males.
2-Generation reproduction study.
LOAEL = 3 (males), not determined (females) mg/kg/day based
on sperm abnormalities in F1 males.
MOE = 100 (residential)
Rat 28-Day Dermal Toxicity Study.
LOAEL = 250 (females) mg/kg/day based on increased plasma
glucose, triglyceride levels, and alkaline phosphatase activity
and inflammatory cell infiltration in the liver and necrosis of
single hepatocytes in females.
2-Generation reproduction study.
LOAEL = 1.8 mg/kg/day based on increased incidence and severity of tubular atrophy in testes of F1 generation males.
2-Generation reproduction study.
LOAEL = 3 (males), not determined (females) mg/kg/day based
on sperm abnormalities in F1 males.
Exposure/scenario
Dermal (all durations)
(Adults).
Dermal (all durations)
(infants/children 1–6
yrs).
Inhalation (all durations)
MOE = 100 (residential)
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population
(intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference
dose. MOE = margin of exposure. LOC = level of concern. mg/kg/day = milligrams/kilogram/day.
rmajette on DSK2TPTVN1PROD with PROPOSALS
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to thiamethoxam, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing thiamethoxam tolerances in 40
CFR 180.565. EPA assessed dietary
exposures from thiamethoxam in food
as follows:
For both acute and chronic exposure
assessments for thiamethoxam, EPA
combined residues of clothianidin
coming from thiamethoxam with
residues of thiamethoxam per se. As
discussed in this unit, thiamethoxam’s
major metabolite is CGA–322704, which
is also the registered active ingredient in
clothianidin. Available information
indicates that thiamethoxam and
clothianidin have different toxicological
effects in mammals and should be
assessed separately; however, these
exposure assessments for this action
incorporated the total residue of
thiamethoxam and clothianidin from
use of thiamethoxam because the total
residue for each commodity for which
thiamethoxam has a tolerance has not
been separated between thiamethoxam
and its clothianidin metabolite. The
combining of these residues, as was
done in this assessment, results in
highly conservative estimates of dietary
exposure and risk. A separate
assessment was done for clothianidin.
The clothianidin assessment included
clothianidin residues from use of
VerDate Mar<15>2010
15:16 Mar 01, 2012
Jkt 226001
clothianidin as a pesticide and
clothianidin residues from use of
thiamethoxam on those commodities for
which the pesticide clothianidin does
not have a tolerance. As to these
commodities, EPA has separated total
residues between thiamethoxam and
clothianidin.
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure. Such effects were identified
for thiamethoxam. In estimating acute
dietary exposure, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) 1994–1996 and 1998
Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII). For
residue levels in food, EPA assumed
tolerance level residues of
thiamethoxam and clothianidin. It was
further assumed that 100% of crops
with registered or requested uses of
thiamethoxam and 100% of crops with
registered or requested uses of
clothianidin were treated.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA used the food
consumption data from the USDA 1994–
1996 and 1998 CSFII. For residue levels
in food, EPA assumed tolerance level
and/or anticipated residues (averages)
from field trial data. It was again
assumed that 100% of crops with
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
registered or requested uses of
thiamethoxam and 100% of crops with
registered or requested uses of
clothianidin were treated.
A complete listing of the inputs used
in these assessments can be found in the
following documents: ‘‘Thiamethoxam.
Acute and Chronic Aggregate Dietary
(Food and Drinking Water) Exposure
and Risk Assessments for the Section 3
Registration on Crop Group 15/16
Commodities’’ available in the docket
EPA–HQ–OPP–2010–1079, at http://
www.regulations.gov; and
‘‘Clothianidin—Acute and Chronic
Aggregate Dietary (Food and Drinking
Water) Exposure and Risk Assessments
to Evaluate Requested Uses on Mustard
Seed and Requested uses of
Thiamethoxam on Peanuts, in FoodHandling Establishments, and as a Seed
Treatment for Cereal Grains,’’ available
in the docket EPA–HQ–OPP–2008–
0945, at http://www.regulations.gov.
iii. Cancer. EPA concluded that
thiamethoxam is ‘‘not likely to be
carcinogenic to humans’’ based on
convincing evidence that a nongenotoxic mode of action for liver
tumors was established in the mouse,
and that the carcinogenic effects are a
result of a mode of action dependent on
sufficient amounts of a hepatotoxic
metabolite produced persistently. The
non-cancer (chronic) assessment is
sufficiently protective of the key events
(perturbation of liver metabolism,
hepatotoxicity/regenerative
proliferation) in the animal mode of
E:\FR\FM\02MRR1.SGM
02MRR1
rmajette on DSK2TPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations
action for cancer and thus a separate
exposure assessment pertaining to
cancer risk is not necessary. Because
clothianidin is not expected to pose a
cancer risk, a quantitative dietary
exposure assessment for the purposes of
assessing cancer risk was not
conducted.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for thiamethoxam in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
thiamethoxam. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at http://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the Tier 1 Rice Model for
surface water and the Screening
Concentration in Ground Water (SCI–
GROW) model for ground water, the
estimated drinking water concentrations
(EDWCs) of thiamethoxam for acute
exposures are estimated to be 0.13177
ppm for surface water and 0.00466 ppm
for ground water. The chronic exposure
for surface water and ground water is
estimated to be 0.01131 ppm and
0.00466 ppm respectively. Modeled
estimates of drinking water
concentrations were directly entered
into the dietary exposure model.
Since clothianidin is not a significant
degradate of thiamethoxam in surface
water or ground water sources of
drinking water, it was not included in
the EDWCs for the thiamethoxam
dietary assessment. For the clothianidin
assessments, the EDWC value of 0.0724
ppm for clothianidin was incorporated
into the acute and chronic dietary
assessments.
A complete listing of the inputs used
in these assessments can be found in the
following documents: ‘‘Thiamethoxam.
Acute and Chronic Aggregate Dietary
(Food and Drinking Water) Exposure
and Risk Assessments for the Section 3
Registration on Crop Group 15/16
Commodities’’ available in the docket
EPA–HQ–OPP–2010–1079, at http://
www.regulations.gov; and ‘‘Tier I
Drinking Water Exposure Assessment
for the Section 3 New Uses of
Clothianidin on Rice and Leafy
Vegetables,’’ available in the docket
EPA–HQ–OPP–2008–0945, at http://
www.regulations.gov.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
VerDate Mar<15>2010
15:16 Mar 01, 2012
Jkt 226001
Thiamethoxam is currently registered
for the following uses that could result
in residential exposures: Turfgrass on
golf courses, residential lawns,
commercial grounds, parks,
playgrounds, athletic fields, landscapes,
interiorscapes, sod farms, and indoor
crack and crevice or spot treatments to
control insects in residential settings.
EPA assessed residential exposure using
the assumption that thiamethoxam is
applied by commercial applicators only.
However, entering areas previously
treated with thiamethoxam could lead
to exposures for adults and children. As
a result, risk assessments have been
completed for postapplication scenarios.
Short-term postapplication exposures
(1 to 30 days of continuous exposure)
may occur as a result of activities on
treated turf or entering indoor areas
previously treated with a thiamethoxam
indoor crack and crevice product. EPA
combined all non-dietary sources of
children’s post application exposure to
obtain an estimate of potential
combined exposure. These scenarios
consisted of dermal postapplication
exposure and oral (hand-to-mouth)
exposures for children 3 to 6 years of
age.
A complete listing of the inputs used
in these assessments can be found in the
document ‘‘Thiamethoxam—Human
Health Risk Assessment for Crop Group
15 (including buckwheat, pearl millet,
proso millet, oats, rye, teosinte, triticale)
and Crop Group 16 Commodities
(forage, fodder and straw of cereal grains
group)’’ in docket ID number EPA–HQ–
OPP–2010–1079 at http://
www.regulations.gov. Further
information regarding EPA standard
assumptions and generic inputs for
residential exposures may be found at
http://www.epa.gov/pesticides/trac/
science/trac6a05.pdf.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Thiamethoxam is a member of the
neonicotinoid class of pesticides and
produces, as a metabolite, another
neonicotinoid, clothianidin. Structural
similarities or common effects do not
constitute a common mechanism of
toxicity. Evidence is needed to establish
that the chemicals operate by the same,
or essentially the same sequence of
major biochemical events. Although
clothianidin and thiamethoxam bind
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
12735
selectively to insect nicotinic
acetylcholine receptors (nAChR), the
specific binding site(s)/receptor(s) for
clothianidin, thiamethoxam, and the
other neonicotinoids are unknown at
this time. Additionally, the
commonality of the binding activity
itself is uncertain, as preliminary
evidence suggests that clothianidin
operates by direct competitive
inhibition, while thiamethoxam is a
non-competitive inhibitor. Furthermore,
even if future research shows that
neonicotinoids share a common binding
activity to a specific site on insect
nicotinic acetylcholine receptors, there
is not necessarily a relationship between
this pesticidal action and a mechanism
of toxicity in mammals. Structural
variations between the insect and
mammalian nAChRs produce
quantitative differences in the binding
affinity of the neonicotinoids towards
these receptors, which, in turn, confers
the notably greater selective toxicity of
this class towards insects, including
aphids and leafhoppers, compared to
mammals. While the insecticidal action
of the neonicotinoids is neurotoxic, the
most sensitive regulatory endpoint for
thiamethoxam is based on unrelated
effects in mammals, including effects on
the liver, kidney, testes, and
hematopoietic system. Additionally, the
most sensitive toxicological effect in
mammals differs across the
neonicotinoids (e.g., testicular tubular
atrophy with thiamethoxam;
mineralized particles in thyroid colloid
with imidacloprid).
Thus, EPA has not found
thiamethoxam or clothianidin to share a
common mechanism of toxicity with
any other substances. For the purposes
of this tolerance action, therefore, EPA
has assumed that thiamethoxam and
clothianidin do not have a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s Web site at http://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines,
based on reliable data, that a different
margin of safety will be safe for infants
and children. This additional margin of
E:\FR\FM\02MRR1.SGM
02MRR1
rmajette on DSK2TPTVN1PROD with PROPOSALS
12736
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations
safety is commonly referred to as the
FQPA SF. In applying this provision,
EPA either retains the default value of
10X, or uses a different additional safety
factor when reliable data available to
EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity.
In the developmental studies, there is
no evidence of increased quantitative or
qualitative susceptibility of rat or rabbit
fetuses to in utero exposure to
thiamethoxam. The developmental
NOAELs are either higher than or equal
to the maternal NOAELs. The
toxicological effects in fetuses do not
appear to be any more severe than those
in the dams or does. In the rat
developmental neurotoxicity study,
there was no quantitative evidence of
increased susceptibility; however, there
was increased qualitative susceptibility
because the effects in the pups (reduced
brain weight and significant changes in
brain morphometric measurements)
were considered to be more severe than
findings in the dams (decreased body
weight gain and food consumption).
There is evidence of increased
quantitative susceptibility for male pups
in both 2-generation reproductive
studies. In one study, there are no
toxicological effects in the dams;
whereas, for the pups, reduced
bodyweights are observed at the highest
dose level, starting on day 14 of
lactation. This contributes to an overall
decrease in bodyweight gain during the
entire lactation period. The
reproductive effects in males appear in
the F1 generation in the form of
increased incidence and severity of
testicular tubular atrophy (see
developmental/reproductive section).
These data are considered to be
evidence of increased quantitative
susceptibility for male pups (increased
incidence of testicular tubular atrophy
at 1.8 mg/kg/day) when compared to the
parents (hyaline changes in renal
tubules at 61 mg/kg/day; NOAEL is 1.8
mg/kg/day).
In a more recent 2-generation
reproduction study, the most sensitive
effect was sperm abnormalities at 3 mg/
kg/day (the NOAEL is 1.2 mg/kg/day) in
the F1 males. This study also indicates
increased susceptibility for the offspring
for this effect.
Although there is evidence of
increased quantitative susceptibility for
male pups in both reproductive studies,
NOAELs and LOAELs were established
in these studies and the Agency selected
the NOAEL for testicular effects in F1
pups as the basis for risk assessment.
The Agency has confidence that the
NOAEL selected for risk assessment is
protective of the most sensitive effect
VerDate Mar<15>2010
15:16 Mar 01, 2012
Jkt 226001
(testicular) for the most sensitive
subgroup (pups) observed in the
toxicological database.
3. Conclusion. i. In the final rule
published in the Federal Register of
January 5, 2005 (70 FR 708) (FRL–7689–
7), EPA had previously determined that
the FQPA SF should be retained at 10X
for thiamethoxam, based on the
following factors: Effects on endocrine
organs observed across species;
significant decrease in alanine amino
transferase levels in companion animal
studies and in dog studies; the mode of
action of this chemical in insects
(interferes with the nicotinic
acetylcholine receptors of the insect’s
nervous system); the transient clinical
signs of neurotoxicity in several studies
across species; and the suggestive
evidence of increased quantitative
susceptibility in the rat reproduction
study. Since that determination, EPA
has received and reviewed a
developmental neurotoxicity (DNT)
study in rats, and an additional
reproduction study in rats. Taking the
results of these studies into account, as
well as the rest of the data on
thiamethoxam, EPA has determined that
reliable data show the safety of infants
and children would be adequately
protected if the FQPA SF were reduced
to 1X (June 23, 2010, 75 FR 35653; FRL–
8830–4); (June 22, 2007, 72 FR 34401).
That decision is based on the following
findings:
a. The toxicity database for
thiamethoxam is largely complete,
including acceptable/guideline
developmental toxicity, 2-generation
reproduction, and DNT studies designed
to detect adverse effects on the
developing organism, which could
result from the mechanism that may
have produced the decreased alanine
amino transferase levels. The available
data for thiamethoxam show the
potential for immunotoxic effects. In the
subchronic dog study, leukopenia
(decreased white blood cells) was
observed in females only, at the highest
dose tested (HDT) of 50 mg/kg/day; the
NOAEL for this effect was 34 mg/kg/
day. The overall study NOAEL was 9.3
mg/kg/day in females (8.2 mg/kg/day in
males) based on hematology and other
clinical chemistry findings at the
LOAEL of 34 mg/kg/day (32 mg/kg/day
in males). In the subchronic mouse
study, decreased spleen weights were
observed in females at 626 mg/kg/day;
the NOAEL for this effect was the next
lowest dose of 231 mg/kg/day. The
overall study NOAEL was 1.4 mg/kg/
day (males) based on increased
hepatocyte hypertrophy observed at the
LOAEL of 14.3 mg/kg/day. The
decreased absolute spleen weights were
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
considered to be treatment related, but
were not statistically significant at 626
mg/kg/day or at the HDT of 1,163 mg/
kg/day. Since spleen weights were not
decreased relative to body weights, the
absolute decreases may have been
related to the decreases in body weight
gain observed at higher doses. Overall,
the Agency has a low concern for the
potential for immunotoxicity related to
these effects for the following reasons:
In general, the Agency does not consider
alterations in hematology parameters
alone to be a significant indication of
potential immunotoxicity. In the case of
thiamethoxam, high-dose females in the
subchronic dog study had slight
microcytic anemia as well as leukopenia
characterized by reductions in
neutrophils, lymphocytes and
monocytes; the leukopenia was
considered to be related to the anemic
response to exposure. Further,
endpoints and doses selected for risk
assessment are protective of the
observed effects on hematology. Spleen
weight decreases, while considered
treatment-related, were associated with
decreases in body weight gain, and were
not statistically significant. In addition,
spleen weight changes occurred only at
very high doses, more than 70 times
higher than the doses selected for risk
assessment.
In addition to the previous
considerations, a 28-day
immunotoxicity study in female mice
was recently received and has
undergone a preliminary review. There
were no immunotoxic effects observed
at doses exceeding the limit dose of
1,000 mg/kg/day.
b. For the reasons discussed in Unit
III.D.2., there is low concern for an
increased susceptibility in the young.
c. Although there is evidence of
neurotoxicity after acute exposure to
thiamethoxam at doses of 500 mg/kg/
day including drooped palpebral
closure, decrease in rectal temperature
and locomotor activity and increase in
forelimb grip strength, no evidence of
neuropathology was observed. These
effects occurred at doses at least 14-fold
and 416-fold higher than the doses used
for the acute, and chronic risk
assessments, respectively; thus, there is
low concern for these effects since it is
expected that the doses used for
regulatory purposes would be protective
of the effects noted at much higher
doses.
In the developmental neurotoxicity
study (DNT), there was no evidence of
neurotoxicity in the dams exposed up to
298.7 mg/kg/day; a dose that was
associated with decreases in body
weight gain and food consumption. In
pups exposed to 298.7 mg/kg/day, there
E:\FR\FM\02MRR1.SGM
02MRR1
rmajette on DSK2TPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations
were significant reductions in absolute
brain weight and size (i.e., length and
width of the cerebellum was less in
males on day 12, and there were
significant decreases in Level 3–5
measurements in males and in Level 4–
5 measurements in females on day 63).
However, there is low concern for this
increased qualitative susceptibility
observed in the DNT study because the
doses and endpoints selected for risk
assessment are protective of the effects
in the offspring. As noted previously,
for risk assessment the Agency selected
the NOAEL for testicular effects in F1
pups based on two reproductive toxicity
studies to be protective of all sensitive
subpopulations.
d. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed using tolerance-level
and/or anticipated residues that are
based on reliable field trial data
observed in the thiamethoxam field
trials. Although there is available
information indicating that
thiamethoxam and clothianidin have
different toxicological effects in
mammals and should be assessed
separately, the residues of each have
been combined in these assessments to
ensure that the estimated exposures of
thiamethoxam do not underestimate
actual potential thiamethoxam
exposures. An assumption of 100
percent crop treated (PCT) was made for
all foods evaluated in the assessments.
For the acute and chronic assessments,
the EDWCs of 131.77 parts per billion
(ppb) and 11.3 ppb, respectively, were
used to estimate exposure via drinking
water. Compared to the results from
small scale prospective ground water
studies where the maximum observed
residue levels from any monitoring well
were 1.0 ppb for thiamethoxam and 0.73
ppb for clothianidin, the modeled
estimates are protective of what actual
exposures are likely to be. EPA used
similarly conservative (protective)
assumptions to assess postapplication
exposure to children and adults
including incidental oral exposure of
toddlers. These assessments will not
underestimate the exposure and risks
posed by thiamethoxam.
ii. In the final rule published in the
Federal Register of February 6, 2008 (73
FR 6851) (FRL–8346–9), EPA had
previously determined that the FQPA
SF for clothianidin should be retained at
10X because EPA had required the
submission of a developmental
immunotoxicity study to address the
combination of evidence of decreased
absolute and adjusted organ weights of
the thymus and spleen in multiple
studies in the clothianidin database, and
VerDate Mar<15>2010
15:16 Mar 01, 2012
Jkt 226001
evidence showing that juvenile rats in
the 2-generation reproduction study
appear to be more susceptible to these
potential immunotoxic effects. In the
absence of a developmental
immunotoxicity study, EPA concluded
that there was sufficient uncertainty
regarding immunotoxic effects in the
young that the 10X FQPA factor should
be retained as a database uncertainty
factor.
Since that determination, EPA has
received and reviewed an acceptable/
guideline developmental
immunotoxicity study, which
demonstrated no treatment-related
effects. Taking the results of this study
into account, as well as the rest of the
data on clothianidin, EPA has
determined that reliable data show the
safety of infants and children would be
adequately protected if the FQPA SF for
clothianidin were reduced to 1X
(February 11, 2011, 76 FR 7712) (FRL–
8858–3). That decision is based on the
following findings:
a. The toxicity database for
clothianidin is complete. As noted, the
prior data gap concerning
developmental immunotoxicity has
been addressed by the submission of an
acceptable developmental
immunotoxicity study.
b. A rat developmental neurotoxicity
study is available and shows evidence
of increased quantitative susceptibility
of offspring. However, EPA considers
the degree of concern for the
developmental neurotoxicity study to be
low for prenatal and postnatal toxicity
because the NOAEL and LOAEL were
well characterized, and the doses and
endpoints selected for risk assessment
are protective of the observed
susceptibility; therefore, there are no
residual concerns regarding effects in
the young.
c. While the rat multi-generation
reproduction study showed evidence of
increased quantitative susceptibility of
offspring compared to adults, the degree
of concern is low because the study
NOAEL and LOAEL have been selected
for risk assessment purposes for relevant
exposure routes and durations. In
addition, the potential immunotoxic
effects observed in the study have been
further characterized with the
submission of a developmental
immunotoxicity study that showed no
evidence of susceptibility. As a result,
there are no concerns or residual
uncertainties for prenatal and postnatal
toxicity after establishing toxicity
endpoints and traditional UFs to be
used in the risk assessment for
clothianidin.
d. There are no residual uncertainties
identified in the exposure databases.
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
12737
The dietary food exposure assessments
were performed based on assumptions
that were judged to be highly
conservative and health-protective for
all durations and population subgroups,
including tolerance-level residues,
adjustment factors from metabolite data,
empirical processing factors, and 100
PCT for all commodities. Additionally,
EPA made conservative (protective)
assumptions in the ground water and
surface water modeling used to assess
exposure to clothianidin in drinking
water. EPA used similarly conservative
assumptions to assess post-application
exposure of children and adults as well
as incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by clothianidin.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
thiamethoxam will occupy 9.5% of the
aPAD for All infants (<1 year), the
population group receiving the greatest
exposure. Acute dietary exposure from
food and water to clothianidin is
estimated to occupy 23% of the aPAD
for children 1 to 2 years old, the
population group receiving the greatest
exposure.
2. Chronic risk. In examining chronic
aggregate risk, EPA has assumed that the
only pathway of exposure relevant to
that time frame is dietary exposure.
Using this assumption for chronic
exposure, EPA has concluded that
chronic exposure to thiamethoxam from
food and water will utilize 43% of the
cPAD for Children 1 to 2 years old, the
population group receiving the greatest
exposure. Chronic exposure to
clothianidin from food and water will
utilize 19% of the cPAD for children 1
to 2 years old, the population group
receiving the greatest exposure.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
E:\FR\FM\02MRR1.SGM
02MRR1
rmajette on DSK2TPTVN1PROD with PROPOSALS
12738
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations
(considered to be a background
exposure level). Thiamethoxam is
currently registered for uses that could
result in short-term residential
exposure, and the Agency has
determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to thiamethoxam.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures for thiamethoxam
result in aggregate MOEs of: 370 for the
general U.S. population; 490 for all
infants; 440 for children 1 to 2 years;
450 for children 3 to 5 years; 370 for
children 6 to 12 years; 380 for youth 13
to 19 years, adults 20 to 49 years, adults
50+ years, and females 13 to 49 years.
Because EPA’s level of concern for
thiamethoxam is a MOE of 100 or
below, these MOEs are not of concern.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures for clothianidin
result in aggregate MOEs of: 1,200 for
the general U.S. population; 480 for all
infants (<1 year); 370 for children 1 to
2 years; 490 for children 3 to 5 years;
1,000 for children 6 to 12 years; 1,400
for youth 13 to 19 years, adults 20–49
years, and females 13 to 49 years; and
1,300 for adults 50+ years. Because
EPA’s level of concern for clothianidin
is a MOE of 100 or below, these MOEs
are not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Thiamethoxam is currently registered
for uses that could result in
intermediate-term residential exposure,
and the Agency has determined that it
is appropriate to aggregate chronic
exposure through food and water with
intermediate-term residential exposures
to thiamethoxam.
Using the exposure assumptions
described in this unit for intermediateterm exposures, EPA has concluded that
the combined intermediate-term food,
water, and residential exposures for
thiamethoxam result in aggregate MOEs
of: 370 for the general U.S. population;
540 for all infants (<1 year); 470 for
children 1 to 2 years; 490 for children
3 to 5 years; 370 for children 6 to 12
years; 380 for youth 13 to 19 years,
adults 20 to 49 years, adults 50+ years,
and females 13 to 49 years. Because
EPA’s level of concern for
VerDate Mar<15>2010
15:16 Mar 01, 2012
Jkt 226001
thiamethoxam is a MOE of 100 or
below, these MOEs are not of concern.
Using the exposure assumptions
described in this unit for intermediate
exposures, EPA has concluded the
combined intermediate food, water, and
residential exposures for clothianidin
result in aggregate MOEs of: 1,200 for
the general U.S. population; 480 for all
infants (<1 year); 370 for children 1 to
2 years; 490 for children 3 to 5 years;
1,000 for children 6 to 12 years; 1,400
for youth 13 to 19 years, adults 20 to 49
years, and females 13 to 49 years; and
1,300 for adults 50+ years. Because
EPA’s level of concern for clothianidin
is a MOE of 100 or below, these MOEs
are not of concern.
5. Aggregate cancer risk for U.S.
population. The Agency has classified
thiamethoxam as not likely to be a
human carcinogen based on convincing
evidence that a non-genotoxic mode of
action for liver tumors was established
in the mouse and that the carcinogenic
effects are a result of a mode of action
dependent on sufficient amounts of a
hepatotoxic metabolite produced
persistently. Therefore, thiamethoxam is
not expected to pose a cancer risk.
Clothianidin has been classified as ‘‘not
likely to be a human carcinogen’’ and is
not expected to pose a cancer risk.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to
thiamethoxam or clothianidin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The High Production Liquid
Chromatography (HPLC) Method AG–
675 with ultraviolet (UV) or Mass
Spectrometry (MS) detection was
previously submitted in conjunction
with thiamethoxam petitions. Method
AG–675 has been determined to be
adequate for enforcing the tolerance
expression for residues of thiamethoxam
and CGA–322704 in crop and livestock
commodities. Syngenta Crop Protection,
Inc., has submitted a revised Method
AG–675, i.e., Method GRM.009.04A.
The full extraction steps for plant and
livestock commodities, including the
microwave extraction step for liver,
have been incorporated. The limits of
quantitation (LOQs) of Method
GRM.009.04A have been established at
0.01 ppm each for residues of
thiamethoxam, CGA–322704 and CGA–
265307. Method validation data are
available for Method GRM.009.04A.
The method may be requested from:
Chief, Analytical Chemistry Branch,
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
EPA is increasing the barley grain
tolerance to 0.4 ppm in order to
harmonize with the Codex MRL of 0.4
ppm. The MRL expressions continue to
remain different, as the Codex MRL is
for the parent compound only.
C. Revisions to Petitioned-For
Tolerances
Although the petitioner sought
tolerances for many of the commodities
in Crop Groups 15 and 16, the petitioner
did not request crop group tolerances.
EPA has determined that a tolerance for
either Crop Group 15 or Crop Group 16
commodities is not appropriate except
for Crop Group 15 grains (except
barley), because the use pattern is not
the same for all Crop Group 15
commodities. Specifically, there is a
foliar use on barley and there are much
higher tolerances for barley hay and
straw associated with this foliar use. It
is for similar reasons that a Crop Group
16 tolerance would not be appropriate.
In addition, there are also significant
differences in the tolerances for the
different cereal forages, i.e., wheat
forage at 0.5 ppm, corn forage at 0.10
ppm, and sorghum forage at 0.02 ppm.
Therefore, tolerances for each
individual commodity have been
established by translating residue data
from the most appropriate
representative commodity, except for
grains which all have the same tolerance
(excluding barley). Tolerances are not
required for triticale and wild rice
because these commodities are covered
by the wheat and rice tolerances, as
E:\FR\FM\02MRR1.SGM
02MRR1
12739
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations
specified in 40 CFR 180.1. Tolerances
are also not needed for teosinte forage
and stover as these are not considered
significant livestock feed items and are
not consumed by humans.
rmajette on DSK2TPTVN1PROD with PROPOSALS
V. Conclusion
Therefore, tolerances are established
for residues of thiamethoxam, 3-[(2chloro-5-thiazolyl)methyl]tetrahydro-5methyl-N-nitro-4H-1,3,5-oxadiazin-4imine and its metabolite, N-[(2-chlorothiazol-5-yl)methyl]-N ′-methyl-N ″nitro-guanidine, in or on barley, grain at
0.4 ppm; buckwheat, forage at 0.50 ppm;
buckwheat, hay at 0.02 ppm;
buckwheat, straw at 0.02 ppm; grain,
cereal, group 15, except barley at 0.02
ppm; oat, forage at 0.50 ppm, oat, hay
at 0.02 ppm; oat, straw at 0.02 ppm;
millet, pearl, forage at 0.02 ppm; millet,
pearl, stover at 0.02 ppm; millet, proso,
forage at 0.02 ppm; millet, proso, stover
at 0.02 ppm; millet, proso, straw at 0.02
ppm; rye, forage at 0.50 ppm; rye, straw
at 0.02 ppm. Tolerances are revoked for
corn, field, grain; corn, pop, grain; rice,
grain; sorghum, grain; wheat, grain.
These tolerances are no longer needed,
since residues on these commodities
will be covered by the crop group 15
tolerances being established in this rule.
In addition, administrative
corrections are being made to the
existing tolerances for grain, aspirated
fractions and soybean, hulls, as follows:
The tolerance for grain, aspirated
fractions at 0.08 ppm is being corrected
to grain, aspirated fractions at 2.0 ppm;
the tolerance for soybean, hulls at 2.0
ppm is being corrected to soybean, hulls
at 0.08 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
VerDate Mar<15>2010
16:28 Mar 01, 2012
Jkt 226001
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 17, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.565 paragraph (a) is
revised to read as follows:
■
§ 180.565 Thiamethoxam; tolerances for
residues.
(a) General. Tolerances are
established for residues of the
insecticide thiamethoxam, including its
metabolites and degradates, in or on the
following commodities. Compliance
with the tolerance levels specified
below is to be determined by measuring
only thiamethoxam 3-[(2-chloro-5thiazolyl)methyl]tetrahydro-5-methyl-Nnitro-4H-1,3,5-oxadiazin-4-imine and its
metabolite CGA–322704 N-[(2-chlorothiazol-5-yl)methyl]-N′-methyl-N″-nitroguanidine, calculated as the
stoichiometric equivalent of
thiamethoxam, in or on the following
commodities:
Commodity
Alfalfa, forage .........................
Alfalfa, hay ..............................
Almond, hulls ..........................
Artichoke, globe ......................
Avocado ..................................
Barley, grain ...........................
Barley, hay ..............................
Barley, straw ...........................
Bean, succulent ......................
Berry, low growing, subgroup
13–07G, except cranberry ..
Borage, seed ..........................
Brassica, head and stem, subgroup 5–A ...........................
Brassica, leafy greens, subgroup 5–B ...........................
Buckwheat, forage ..................
Buckwheat, hay ......................
Buckwheat, straw ...................
Bushberry subgroup 13–07B,
except lingonberry and
blueberry, lowbush ..............
Canistel ...................................
Canola, seed ..........................
Cattle, meat ............................
E:\FR\FM\02MRR1.SGM
02MRR1
Parts per
million
0.05
0.12
1.2
0.45
0.40
0.4
0.40
0.40
0.02
0.30
0.02
4.5
3.0
0.50
0.02
0.02
0.20
0.40
0.02
0.02
12740
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Rules and Regulations
rmajette on DSK2TPTVN1PROD with PROPOSALS
Commodity
Parts per
million
Cattle, meat byproducts .........
Citrus, dried pulp ....................
Coffee, bean, green 1 .............
Corn, field, forage ...................
Corn, field, stover ...................
Corn, pop, forage ...................
Corn, pop, stover ....................
Corn, sweet, forage ................
Corn, sweet, kernel plus cob
with husks removed ............
Corn, sweet, stover ................
Cotton, gin byproducts ...........
Cotton, undelinted seed .........
Crambe, seed .........................
Cranberry ................................
Flax, seed ...............................
Food commodities and feed
commodities (other than
those covered by a higher
tolerance as a result of use
on growing crops) in food/
feed handling establishments ..................................
Fruit, citrus, group 10 .............
Fruit, pome, group 11 .............
Fruit, small, vine climbing,
subgroup 13–07F, except
fuzzy kiwifruit .......................
Fruit, stone, group 12 .............
Goat, meat ..............................
Goat, meat byproducts ...........
Grain, aspirated fractions .......
Grain, cereal, group 15, except barley ..........................
Grape, raisin ...........................
Hog, meat ...............................
Hog, meat byproducts ............
Hop, dried cones ....................
Horse, meat ............................
Horse, meat byproducts .........
Mango .....................................
Milk .........................................
Millet, pearl, forage .................
Millet, pearl, stover .................
Millet, proso, forage ................
Millet, proso, stover ................
Millet, proso, straw .................
Oat, forage ..............................
Oat, hay ..................................
Oat, straw ...............................
Peanut ....................................
Peanut, hay ............................
Peanut, meal ..........................
Peppermint, tops ....................
Pistachio .................................
Potato .....................................
Radish, tops ............................
Rapeseed, seed .....................
Rye, forage .............................
Rye, straw ...............................
Sapodilla .................................
Sapote, black ..........................
Sapote, mamey ......................
Sheep, meat ...........................
Sheep, meat byproducts ........
Sorghum, forage .....................
Sorghum, grain, stover ...........
Soybean, hulls ........................
Spearmint, tops ......................
Star apple ...............................
Sunflower ................................
Tomato, paste .........................
Vegetable, cucurbit, group 9 ..
VerDate Mar<15>2010
15:16 Mar 01, 2012
0.04
0.60
0.05
0.10
0.05
0.10
0.05
0.10
0.02
0.05
1.5
0.10
0.02
0.02
0.02
Parts per
million
Commodity
Vegetable, fruiting, group 8 ....
Vegetable, leafy, except brassica, group 4 .......................
Vegetable, legume, group 6 ...
Vegetable, root, subgroup 1A
Vegetable, tuberous and
corm, except potato, subgroup 1D .............................
Wheat, forage .........................
Wheat, hay .............................
Wheat, straw ...........................
0.25
4.0
0.02
0.05
0.02
0.50
0.02
0.02
1 There are no U.S. registrations as of September 17, 2003.
*
*
*
*
*
[FR Doc. 2012–4983 Filed 3–1–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
0.02
0.40
0.2
0.20
0.5
0.02
0.04
2.0
0.02
0.30
0.02
0.02
0.10
0.02
0.04
0.40
0.02
0.02
0.02
0.02
0.02
0.02
0.50
0.02
0.02
0.05
0.25
0.15
1.5
0.02
0.25
0.80
0.02
0.50
0.02
0.40
0.40
0.40
0.02
0.04
0.02
0.02
0.08
1.5
0.40
0.02
0.80
0.2
Jkt 226001
40 CFR Part 180
[EPA–HQ–OPP–2010–0524; FRL–9337–9]
Trinexapac-ethyl; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of trinexapacethyl in or on multiple commodities
which are identified and discussed later
in this document. Syngenta Crop
Protection, Inc. requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
March 2, 2012. Objections and requests
for hearings must be received on or
before May 1, 2012, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2010–0524. All documents in the
docket are listed in the docket index
available at http://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
http://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
ADDRESSES:
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Bethany Benbow, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 347–8072; email address:
benbow.bethany@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at http://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl. To access the
OCSPP test guidelines referenced in this
document electronically, please go to
http://www.epa.gov/ocspp and select
‘‘Test Methods and Guidelines.’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
E:\FR\FM\02MRR1.SGM
02MRR1

Agencies

[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Rules and Regulations]
[Pages 12731-12740]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4983]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-1079; FRL-9331-8]
Thiamethoxam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
thiamethoxam in or on multiple commodities which are identified and
discussed later in this document. Syngenta Crop Protection, Inc.
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective March 2, 2012. Objections and
requests for hearings must be received on or before May 1, 2012, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-1079. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
[[Page 12732]]
FOR FURTHER INFORMATION CONTACT: Gene Benbow, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 347-0235; email address: Benbow.Gene@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-1079 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 1, 2012. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-1079, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F7805) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419. The petition requested that 40 CFR 180.565 be amended by
establishing tolerances for residues of the insecticide thiamethoxam,
3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine and its metabolite, N-[(2-chloro-thiazol-5-
yl)methyl]-N'-methyl-N''-nitro-guanidine], in or on: buckwheat, grain
at 0.02 per million (ppm); buckwheat, forage at 0.50 ppm; buckwheat,
hay at 0.02 ppm; buckwheat, straw at 0.02 ppm; oat, grain at 0.02 ppm;
oat, forage at 0.50 ppm, oat, hay at 0.02 ppm; oat, straw at 0.02 ppm;
millet, pearl, grain at 0.02 ppm; millet, pearl, forage at 0.02 ppm;
millet, pearl, stover at 0.02 ppm; millet, proso, grain at 0.02 ppm;
millet, proso, forage at 0.02 ppm; millet, proso, stover at 0.02 ppm;
millet, proso, straw at 0.02 ppm; rye, grain at 0.02 ppm; rye, forage
at 0.50 ppm; rye, straw at 0.02 ppm; teosinte, grain at 0.02 ppm;
teosinte, forage at 0.10 ppm; teosinte, stover at 0.05 ppm; triticale,
grain at 0.02 ppm; triticale, forage at 0.05 ppm; triticale, hay at
0.02 ppm; triticale, straw at 0.02 ppm; wild rice, grain at 0.02 ppm.
That notice referenced a summary of the petition prepared by Syngenta
Crop Protection, Inc., the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for thiamethoxam including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with thiamethoxam
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
[[Page 12733]]
Thiamethoxam shows toxicological effects primarily in the liver,
kidney, testes, and hematopoietic system. In addition, developmental
neurological effects were observed in rats. This developmental effect
is being used to assess risks associated with acute exposures to
thiamethoxam, and the liver and testicular effects are the basis for
assessing longer term exposures. Although thiamethoxam causes liver
tumors in mice, the Agency has classified thiamethoxam as ``not likely
to be carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse
and that the carcinogenic effects are a result of a mode of action
dependent on sufficient amounts of a hepatotoxic metabolite produced
persistently. The non-cancer (chronic) assessment is sufficiently
protective of the key events (perturbation of liver metabolism,
hepatotoxicity/regenerative proliferation) in the animal mode of action
for cancer.
Specific information on the studies received and the nature of the
adverse effects caused by thiamethoxam as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in section 4.5.1 in the document ``Thiamethoxam--
Human Health Risk Assessement for Crop Group 15 (including buckwheat,
pearl millet, proso millet, oats, rye, teosinte, triticale) and Crop
Group 16 Commodities (forage, fodder and straw of cereal grains
group)'' in docket ID number EPA-HQ-OPP-2010-1079 at http://www.regulations.gov.
Thiamethoxam produces a metabolite known as CGA-322704 (referred to
in the remainder of this rule as clothianidin). Clothianidin is also
registered as a pesticide. While some of the toxic effects observed
following testing with thiamethoxam and clothianidin are similar, the
available information indicates that thiamethoxam and clothianidin have
different toxicological effects in mammals and should be assessed
separately. A separate risk assessment of clothianidin has been
completed in conjunction with the registration of clothianidin. The
most recent assessment, which provides details regarding the toxicology
of clothianidin, is available in the docket EPA-HQ-OPP-2008-0945, at
http://www.regulations.gov. Refer to the document ``Clothianidin: Human
Health Risk Assessment for the Requested New Use on Mustard Seen as
well as New Uses of Thiamethoxam on Peanuts, Alfalfa, in Food-Handling
Establishments, and as a Seed Treatment for Cereal Grains.''
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors (U/S F) are used in conjunction
with the POD to calculate a safe exposure level--generally referred to
as a population-adjusted dose (PAD) or a reference dose (RfD)--and a
safe margin of exposure (MOE). For non-threshold risks, the Agency
assumes that any amount of exposure will lead to some degree of risk.
Thus, the Agency estimates risk in terms of the probability of an
occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for thiamethoxam used for
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Thiamethoxam for Use in Human Health Risk Assessment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Point of departure and uncertainty/ RfD, PAD, LOC for risk
Exposure/scenario safety factors assessment Study and toxicological effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute dietary (All populations NOAEL = 34.5 mg/kg/day Acute RfD = 0.35 mg/kg/ Rat Developmental Neurotoxicity study.
including infants and children). UFA = 10x day. LOAEL = 298.7 mg/kg/day based on delayed sexual
UFH = 10x aPAD = 0.35 mg/kg/day... maturation in male pups, and reduced brain
FQPA SF = 1 morphometric measurements.
Chronic dietary (All populations NOAEL = 1.2 mg/kg/day Chronic RfD = 0.012 mg/ 2-Generation reproduction study.
including infants and children). UFA = 10x kg/day. 1. LOAEL = 1.8 mg/kg/day based on increased
UFH = 10x cPAD = 0.012 mg/kg/day.. incidence and severity of tubular atrophy in
FQPA SF = 1 testes of F1 generation males.
2-Generation reproduction study.
2. LOAEL = 3 (males), not determined (females) mg/
kg/day based on sperm abnormalities in F1 males.
Incidental oral (all durations)....... NOAEL = 8.23 mg/kg/day MOE = 100 (residential). 90-day Dog study.
UFA = 10x LOAEL = 32 (males) 33.9 (females) mg/kg/day based
UFH = 10x on slightly prolonged prothrombin times and
FQPA SF = 1 decreased plasma albumin and A/G ratio (both
sexes); decreased calcium levels and ovary
weights and delayed maturation in the ovaries
(females); decreased cholesterol and
phospholipid levels, testis weights,
spermatogenesis, and spermatic giant cells in
testes (males).
[[Page 12734]]
Dermal (all durations) (Adults)....... Oral study NOAEL = 1.2 mg/kg/day MOE = 100 (residential). 2-Generation reproduction study.
(dermal absorption rate = 5%) LOAEL = 1.8 mg/kg/day based on increased
UFA = 10x incidence and severity of tubular atrophy in
UFH = 10x testes of F1 generation males.
FQPA SF = 1 2-Generation reproduction study.
LOAEL = 3 (males), not determined (females) mg/kg/
day based on sperm abnormalities in F1 males.
Dermal (all durations) (infants/ Dermal study NOAEL = 60 mg/kg/day MOE = 100 (residential). Rat 28-Day Dermal Toxicity Study.
children 1-6 yrs). UFA = 10x LOAEL = 250 (females) mg/kg/day based on
UFH = 10x increased plasma glucose, triglyceride levels,
FQPA SF = 1 and alkaline phosphatase activity and
inflammatory cell infiltration in the liver and
necrosis of single hepatocytes in females.
Inhalation (all durations)............ Oral study NOAEL = 1.2 mg/kg/day MOE = 100 (residential). 2-Generation reproduction study.
(inhalation absorption rate = 100% LOAEL = 1.8 mg/kg/day based on increased
of oral absorption) incidence and severity of tubular atrophy in
UFA = 10x testes of F1 generation males.
UFH = 10x 2-Generation reproduction study.
FQPA SF = 1 LOAEL = 3 (males), not determined (females) mg/kg/
day based on sperm abnormalities in F1 males.
--------------------------------------------------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).
FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of
exposure. LOC = level of concern. mg/kg/day = milligrams/kilogram/day.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to thiamethoxam, EPA considered exposure under the petitioned-
for tolerances as well as all existing thiamethoxam tolerances in 40
CFR 180.565. EPA assessed dietary exposures from thiamethoxam in food
as follows:
For both acute and chronic exposure assessments for thiamethoxam,
EPA combined residues of clothianidin coming from thiamethoxam with
residues of thiamethoxam per se. As discussed in this unit,
thiamethoxam's major metabolite is CGA-322704, which is also the
registered active ingredient in clothianidin. Available information
indicates that thiamethoxam and clothianidin have different
toxicological effects in mammals and should be assessed separately;
however, these exposure assessments for this action incorporated the
total residue of thiamethoxam and clothianidin from use of thiamethoxam
because the total residue for each commodity for which thiamethoxam has
a tolerance has not been separated between thiamethoxam and its
clothianidin metabolite. The combining of these residues, as was done
in this assessment, results in highly conservative estimates of dietary
exposure and risk. A separate assessment was done for clothianidin. The
clothianidin assessment included clothianidin residues from use of
clothianidin as a pesticide and clothianidin residues from use of
thiamethoxam on those commodities for which the pesticide clothianidin
does not have a tolerance. As to these commodities, EPA has separated
total residues between thiamethoxam and clothianidin.
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for thiamethoxam. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). For residue levels in food, EPA
assumed tolerance level residues of thiamethoxam and clothianidin. It
was further assumed that 100% of crops with registered or requested
uses of thiamethoxam and 100% of crops with registered or requested
uses of clothianidin were treated.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. For residue levels in food, EPA assumed tolerance level
and/or anticipated residues (averages) from field trial data. It was
again assumed that 100% of crops with registered or requested uses of
thiamethoxam and 100% of crops with registered or requested uses of
clothianidin were treated.
A complete listing of the inputs used in these assessments can be
found in the following documents: ``Thiamethoxam. Acute and Chronic
Aggregate Dietary (Food and Drinking Water) Exposure and Risk
Assessments for the Section 3 Registration on Crop Group 15/16
Commodities'' available in the docket EPA-HQ-OPP-2010-1079, at http://www.regulations.gov; and ``Clothianidin--Acute and Chronic Aggregate
Dietary (Food and Drinking Water) Exposure and Risk Assessments to
Evaluate Requested Uses on Mustard Seed and Requested uses of
Thiamethoxam on Peanuts, in Food-Handling Establishments, and as a Seed
Treatment for Cereal Grains,'' available in the docket EPA-HQ-OPP-2008-
0945, at http://www.regulations.gov.
iii. Cancer. EPA concluded that thiamethoxam is ``not likely to be
carcinogenic to humans'' based on convincing evidence that a non-
genotoxic mode of action for liver tumors was established in the mouse,
and that the carcinogenic effects are a result of a mode of action
dependent on sufficient amounts of a hepatotoxic metabolite produced
persistently. The non-cancer (chronic) assessment is sufficiently
protective of the key events (perturbation of liver metabolism,
hepatotoxicity/regenerative proliferation) in the animal mode of
[[Page 12735]]
action for cancer and thus a separate exposure assessment pertaining to
cancer risk is not necessary. Because clothianidin is not expected to
pose a cancer risk, a quantitative dietary exposure assessment for the
purposes of assessing cancer risk was not conducted.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for thiamethoxam in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of thiamethoxam. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Tier 1 Rice Model for surface water and the Screening
Concentration in Ground Water (SCI-GROW) model for ground water, the
estimated drinking water concentrations (EDWCs) of thiamethoxam for
acute exposures are estimated to be 0.13177 ppm for surface water and
0.00466 ppm for ground water. The chronic exposure for surface water
and ground water is estimated to be 0.01131 ppm and 0.00466 ppm
respectively. Modeled estimates of drinking water concentrations were
directly entered into the dietary exposure model.
Since clothianidin is not a significant degradate of thiamethoxam
in surface water or ground water sources of drinking water, it was not
included in the EDWCs for the thiamethoxam dietary assessment. For the
clothianidin assessments, the EDWC value of 0.0724 ppm for clothianidin
was incorporated into the acute and chronic dietary assessments.
A complete listing of the inputs used in these assessments can be
found in the following documents: ``Thiamethoxam. Acute and Chronic
Aggregate Dietary (Food and Drinking Water) Exposure and Risk
Assessments for the Section 3 Registration on Crop Group 15/16
Commodities'' available in the docket EPA-HQ-OPP-2010-1079, at http://www.regulations.gov; and ``Tier I Drinking Water Exposure Assessment
for the Section 3 New Uses of Clothianidin on Rice and Leafy
Vegetables,'' available in the docket EPA-HQ-OPP-2008-0945, at http://www.regulations.gov.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Thiamethoxam is
currently registered for the following uses that could result in
residential exposures: Turfgrass on golf courses, residential lawns,
commercial grounds, parks, playgrounds, athletic fields, landscapes,
interiorscapes, sod farms, and indoor crack and crevice or spot
treatments to control insects in residential settings. EPA assessed
residential exposure using the assumption that thiamethoxam is applied
by commercial applicators only. However, entering areas previously
treated with thiamethoxam could lead to exposures for adults and
children. As a result, risk assessments have been completed for
postapplication scenarios.
Short-term postapplication exposures (1 to 30 days of continuous
exposure) may occur as a result of activities on treated turf or
entering indoor areas previously treated with a thiamethoxam indoor
crack and crevice product. EPA combined all non-dietary sources of
children's post application exposure to obtain an estimate of potential
combined exposure. These scenarios consisted of dermal postapplication
exposure and oral (hand-to-mouth) exposures for children 3 to 6 years
of age.
A complete listing of the inputs used in these assessments can be
found in the document ``Thiamethoxam--Human Health Risk Assessment for
Crop Group 15 (including buckwheat, pearl millet, proso millet, oats,
rye, teosinte, triticale) and Crop Group 16 Commodities (forage, fodder
and straw of cereal grains group)'' in docket ID number EPA-HQ-OPP-
2010-1079 at http://www.regulations.gov. Further information regarding
EPA standard assumptions and generic inputs for residential exposures
may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Thiamethoxam is a member of the neonicotinoid class of pesticides
and produces, as a metabolite, another neonicotinoid, clothianidin.
Structural similarities or common effects do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same sequence of
major biochemical events. Although clothianidin and thiamethoxam bind
selectively to insect nicotinic acetylcholine receptors (nAChR), the
specific binding site(s)/receptor(s) for clothianidin, thiamethoxam,
and the other neonicotinoids are unknown at this time. Additionally,
the commonality of the binding activity itself is uncertain, as
preliminary evidence suggests that clothianidin operates by direct
competitive inhibition, while thiamethoxam is a non-competitive
inhibitor. Furthermore, even if future research shows that
neonicotinoids share a common binding activity to a specific site on
insect nicotinic acetylcholine receptors, there is not necessarily a
relationship between this pesticidal action and a mechanism of toxicity
in mammals. Structural variations between the insect and mammalian
nAChRs produce quantitative differences in the binding affinity of the
neonicotinoids towards these receptors, which, in turn, confers the
notably greater selective toxicity of this class towards insects,
including aphids and leafhoppers, compared to mammals. While the
insecticidal action of the neonicotinoids is neurotoxic, the most
sensitive regulatory endpoint for thiamethoxam is based on unrelated
effects in mammals, including effects on the liver, kidney, testes, and
hematopoietic system. Additionally, the most sensitive toxicological
effect in mammals differs across the neonicotinoids (e.g., testicular
tubular atrophy with thiamethoxam; mineralized particles in thyroid
colloid with imidacloprid).
Thus, EPA has not found thiamethoxam or clothianidin to share a
common mechanism of toxicity with any other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
thiamethoxam and clothianidin do not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines, based on reliable data, that a
different margin of safety will be safe for infants and children. This
additional margin of
[[Page 12736]]
safety is commonly referred to as the FQPA SF. In applying this
provision, EPA either retains the default value of 10X, or uses a
different additional safety factor when reliable data available to EPA
support the choice of a different factor.
2. Prenatal and postnatal sensitivity. In the developmental
studies, there is no evidence of increased quantitative or qualitative
susceptibility of rat or rabbit fetuses to in utero exposure to
thiamethoxam. The developmental NOAELs are either higher than or equal
to the maternal NOAELs. The toxicological effects in fetuses do not
appear to be any more severe than those in the dams or does. In the rat
developmental neurotoxicity study, there was no quantitative evidence
of increased susceptibility; however, there was increased qualitative
susceptibility because the effects in the pups (reduced brain weight
and significant changes in brain morphometric measurements) were
considered to be more severe than findings in the dams (decreased body
weight gain and food consumption).
There is evidence of increased quantitative susceptibility for male
pups in both 2-generation reproductive studies. In one study, there are
no toxicological effects in the dams; whereas, for the pups, reduced
bodyweights are observed at the highest dose level, starting on day 14
of lactation. This contributes to an overall decrease in bodyweight
gain during the entire lactation period. The reproductive effects in
males appear in the F1 generation in the form of increased
incidence and severity of testicular tubular atrophy (see
developmental/reproductive section). These data are considered to be
evidence of increased quantitative susceptibility for male pups
(increased incidence of testicular tubular atrophy at 1.8 mg/kg/day)
when compared to the parents (hyaline changes in renal tubules at 61
mg/kg/day; NOAEL is 1.8 mg/kg/day).
In a more recent 2-generation reproduction study, the most
sensitive effect was sperm abnormalities at 3 mg/kg/day (the NOAEL is
1.2 mg/kg/day) in the F1 males. This study also indicates
increased susceptibility for the offspring for this effect.
Although there is evidence of increased quantitative susceptibility
for male pups in both reproductive studies, NOAELs and LOAELs were
established in these studies and the Agency selected the NOAEL for
testicular effects in F1 pups as the basis for risk
assessment. The Agency has confidence that the NOAEL selected for risk
assessment is protective of the most sensitive effect (testicular) for
the most sensitive subgroup (pups) observed in the toxicological
database.
3. Conclusion. i. In the final rule published in the Federal
Register of January 5, 2005 (70 FR 708) (FRL-7689-7), EPA had
previously determined that the FQPA SF should be retained at 10X for
thiamethoxam, based on the following factors: Effects on endocrine
organs observed across species; significant decrease in alanine amino
transferase levels in companion animal studies and in dog studies; the
mode of action of this chemical in insects (interferes with the
nicotinic acetylcholine receptors of the insect's nervous system); the
transient clinical signs of neurotoxicity in several studies across
species; and the suggestive evidence of increased quantitative
susceptibility in the rat reproduction study. Since that determination,
EPA has received and reviewed a developmental neurotoxicity (DNT) study
in rats, and an additional reproduction study in rats. Taking the
results of these studies into account, as well as the rest of the data
on thiamethoxam, EPA has determined that reliable data show the safety
of infants and children would be adequately protected if the FQPA SF
were reduced to 1X (June 23, 2010, 75 FR 35653; FRL-8830-4); (June 22,
2007, 72 FR 34401). That decision is based on the following findings:
a. The toxicity database for thiamethoxam is largely complete,
including acceptable/guideline developmental toxicity, 2-generation
reproduction, and DNT studies designed to detect adverse effects on the
developing organism, which could result from the mechanism that may
have produced the decreased alanine amino transferase levels. The
available data for thiamethoxam show the potential for immunotoxic
effects. In the subchronic dog study, leukopenia (decreased white blood
cells) was observed in females only, at the highest dose tested (HDT)
of 50 mg/kg/day; the NOAEL for this effect was 34 mg/kg/day. The
overall study NOAEL was 9.3 mg/kg/day in females (8.2 mg/kg/day in
males) based on hematology and other clinical chemistry findings at the
LOAEL of 34 mg/kg/day (32 mg/kg/day in males). In the subchronic mouse
study, decreased spleen weights were observed in females at 626 mg/kg/
day; the NOAEL for this effect was the next lowest dose of 231 mg/kg/
day. The overall study NOAEL was 1.4 mg/kg/day (males) based on
increased hepatocyte hypertrophy observed at the LOAEL of 14.3 mg/kg/
day. The decreased absolute spleen weights were considered to be
treatment related, but were not statistically significant at 626 mg/kg/
day or at the HDT of 1,163 mg/kg/day. Since spleen weights were not
decreased relative to body weights, the absolute decreases may have
been related to the decreases in body weight gain observed at higher
doses. Overall, the Agency has a low concern for the potential for
immunotoxicity related to these effects for the following reasons: In
general, the Agency does not consider alterations in hematology
parameters alone to be a significant indication of potential
immunotoxicity. In the case of thiamethoxam, high-dose females in the
subchronic dog study had slight microcytic anemia as well as leukopenia
characterized by reductions in neutrophils, lymphocytes and monocytes;
the leukopenia was considered to be related to the anemic response to
exposure. Further, endpoints and doses selected for risk assessment are
protective of the observed effects on hematology. Spleen weight
decreases, while considered treatment-related, were associated with
decreases in body weight gain, and were not statistically significant.
In addition, spleen weight changes occurred only at very high doses,
more than 70 times higher than the doses selected for risk assessment.
In addition to the previous considerations, a 28-day immunotoxicity
study in female mice was recently received and has undergone a
preliminary review. There were no immunotoxic effects observed at doses
exceeding the limit dose of 1,000 mg/kg/day.
b. For the reasons discussed in Unit III.D.2., there is low concern
for an increased susceptibility in the young.
c. Although there is evidence of neurotoxicity after acute exposure
to thiamethoxam at doses of 500 mg/kg/day including drooped palpebral
closure, decrease in rectal temperature and locomotor activity and
increase in forelimb grip strength, no evidence of neuropathology was
observed. These effects occurred at doses at least 14-fold and 416-fold
higher than the doses used for the acute, and chronic risk assessments,
respectively; thus, there is low concern for these effects since it is
expected that the doses used for regulatory purposes would be
protective of the effects noted at much higher doses.
In the developmental neurotoxicity study (DNT), there was no
evidence of neurotoxicity in the dams exposed up to 298.7 mg/kg/day; a
dose that was associated with decreases in body weight gain and food
consumption. In pups exposed to 298.7 mg/kg/day, there
[[Page 12737]]
were significant reductions in absolute brain weight and size (i.e.,
length and width of the cerebellum was less in males on day 12, and
there were significant decreases in Level 3-5 measurements in males and
in Level 4-5 measurements in females on day 63). However, there is low
concern for this increased qualitative susceptibility observed in the
DNT study because the doses and endpoints selected for risk assessment
are protective of the effects in the offspring. As noted previously,
for risk assessment the Agency selected the NOAEL for testicular
effects in F1 pups based on two reproductive toxicity
studies to be protective of all sensitive subpopulations.
d. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed using
tolerance-level and/or anticipated residues that are based on reliable
field trial data observed in the thiamethoxam field trials. Although
there is available information indicating that thiamethoxam and
clothianidin have different toxicological effects in mammals and should
be assessed separately, the residues of each have been combined in
these assessments to ensure that the estimated exposures of
thiamethoxam do not underestimate actual potential thiamethoxam
exposures. An assumption of 100 percent crop treated (PCT) was made for
all foods evaluated in the assessments. For the acute and chronic
assessments, the EDWCs of 131.77 parts per billion (ppb) and 11.3 ppb,
respectively, were used to estimate exposure via drinking water.
Compared to the results from small scale prospective ground water
studies where the maximum observed residue levels from any monitoring
well were 1.0 ppb for thiamethoxam and 0.73 ppb for clothianidin, the
modeled estimates are protective of what actual exposures are likely to
be. EPA used similarly conservative (protective) assumptions to assess
postapplication exposure to children and adults including incidental
oral exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by thiamethoxam.
ii. In the final rule published in the Federal Register of February
6, 2008 (73 FR 6851) (FRL-8346-9), EPA had previously determined that
the FQPA SF for clothianidin should be retained at 10X because EPA had
required the submission of a developmental immunotoxicity study to
address the combination of evidence of decreased absolute and adjusted
organ weights of the thymus and spleen in multiple studies in the
clothianidin database, and evidence showing that juvenile rats in the
2-generation reproduction study appear to be more susceptible to these
potential immunotoxic effects. In the absence of a developmental
immunotoxicity study, EPA concluded that there was sufficient
uncertainty regarding immunotoxic effects in the young that the 10X
FQPA factor should be retained as a database uncertainty factor.
Since that determination, EPA has received and reviewed an
acceptable/guideline developmental immunotoxicity study, which
demonstrated no treatment-related effects. Taking the results of this
study into account, as well as the rest of the data on clothianidin,
EPA has determined that reliable data show the safety of infants and
children would be adequately protected if the FQPA SF for clothianidin
were reduced to 1X (February 11, 2011, 76 FR 7712) (FRL-8858-3). That
decision is based on the following findings:
a. The toxicity database for clothianidin is complete. As noted,
the prior data gap concerning developmental immunotoxicity has been
addressed by the submission of an acceptable developmental
immunotoxicity study.
b. A rat developmental neurotoxicity study is available and shows
evidence of increased quantitative susceptibility of offspring.
However, EPA considers the degree of concern for the developmental
neurotoxicity study to be low for prenatal and postnatal toxicity
because the NOAEL and LOAEL were well characterized, and the doses and
endpoints selected for risk assessment are protective of the observed
susceptibility; therefore, there are no residual concerns regarding
effects in the young.
c. While the rat multi-generation reproduction study showed
evidence of increased quantitative susceptibility of offspring compared
to adults, the degree of concern is low because the study NOAEL and
LOAEL have been selected for risk assessment purposes for relevant
exposure routes and durations. In addition, the potential immunotoxic
effects observed in the study have been further characterized with the
submission of a developmental immunotoxicity study that showed no
evidence of susceptibility. As a result, there are no concerns or
residual uncertainties for prenatal and postnatal toxicity after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment for clothianidin.
d. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on assumptions that were judged to be highly conservative and health-
protective for all durations and population subgroups, including
tolerance-level residues, adjustment factors from metabolite data,
empirical processing factors, and 100 PCT for all commodities.
Additionally, EPA made conservative (protective) assumptions in the
ground water and surface water modeling used to assess exposure to
clothianidin in drinking water. EPA used similarly conservative
assumptions to assess post-application exposure of children and adults
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by clothianidin.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to thiamethoxam will occupy 9.5% of the aPAD for All infants (<1 year),
the population group receiving the greatest exposure. Acute dietary
exposure from food and water to clothianidin is estimated to occupy 23%
of the aPAD for children 1 to 2 years old, the population group
receiving the greatest exposure.
2. Chronic risk. In examining chronic aggregate risk, EPA has
assumed that the only pathway of exposure relevant to that time frame
is dietary exposure. Using this assumption for chronic exposure, EPA
has concluded that chronic exposure to thiamethoxam from food and water
will utilize 43% of the cPAD for Children 1 to 2 years old, the
population group receiving the greatest exposure. Chronic exposure to
clothianidin from food and water will utilize 19% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water
[[Page 12738]]
(considered to be a background exposure level). Thiamethoxam is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to thiamethoxam.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures for thiamethoxam result in aggregate MOEs of:
370 for the general U.S. population; 490 for all infants; 440 for
children 1 to 2 years; 450 for children 3 to 5 years; 370 for children
6 to 12 years; 380 for youth 13 to 19 years, adults 20 to 49 years,
adults 50+ years, and females 13 to 49 years. Because EPA's level of
concern for thiamethoxam is a MOE of 100 or below, these MOEs are not
of concern.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures for clothianidin result in aggregate MOEs of:
1,200 for the general U.S. population; 480 for all infants (<1 year);
370 for children 1 to 2 years; 490 for children 3 to 5 years; 1,000 for
children 6 to 12 years; 1,400 for youth 13 to 19 years, adults 20-49
years, and females 13 to 49 years; and 1,300 for adults 50+ years.
Because EPA's level of concern for clothianidin is a MOE of 100 or
below, these MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Thiamethoxam is currently registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to thiamethoxam.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures for
thiamethoxam result in aggregate MOEs of: 370 for the general U.S.
population; 540 for all infants (<1 year); 470 for children 1 to 2
years; 490 for children 3 to 5 years; 370 for children 6 to 12 years;
380 for youth 13 to 19 years, adults 20 to 49 years, adults 50+ years,
and females 13 to 49 years. Because EPA's level of concern for
thiamethoxam is a MOE of 100 or below, these MOEs are not of concern.
Using the exposure assumptions described in this unit for
intermediate exposures, EPA has concluded the combined intermediate
food, water, and residential exposures for clothianidin result in
aggregate MOEs of: 1,200 for the general U.S. population; 480 for all
infants (<1 year); 370 for children 1 to 2 years; 490 for children 3 to
5 years; 1,000 for children 6 to 12 years; 1,400 for youth 13 to 19
years, adults 20 to 49 years, and females 13 to 49 years; and 1,300 for
adults 50+ years. Because EPA's level of concern for clothianidin is a
MOE of 100 or below, these MOEs are not of concern.
5. Aggregate cancer risk for U.S. population. The Agency has
classified thiamethoxam as not likely to be a human carcinogen based on
convincing evidence that a non-genotoxic mode of action for liver
tumors was established in the mouse and that the carcinogenic effects
are a result of a mode of action dependent on sufficient amounts of a
hepatotoxic metabolite produced persistently. Therefore, thiamethoxam
is not expected to pose a cancer risk. Clothianidin has been classified
as ``not likely to be a human carcinogen'' and is not expected to pose
a cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to thiamethoxam or clothianidin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The High Production Liquid Chromatography (HPLC) Method AG-675 with
ultraviolet (UV) or Mass Spectrometry (MS) detection was previously
submitted in conjunction with thiamethoxam petitions. Method AG-675 has
been determined to be adequate for enforcing the tolerance expression
for residues of thiamethoxam and CGA-322704 in crop and livestock
commodities. Syngenta Crop Protection, Inc., has submitted a revised
Method AG-675, i.e., Method GRM.009.04A. The full extraction steps for
plant and livestock commodities, including the microwave extraction
step for liver, have been incorporated. The limits of quantitation
(LOQs) of Method GRM.009.04A have been established at 0.01 ppm each for
residues of thiamethoxam, CGA-322704 and CGA-265307. Method validation
data are available for Method GRM.009.04A.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
EPA is increasing the barley grain tolerance to 0.4 ppm in order to
harmonize with the Codex MRL of 0.4 ppm. The MRL expressions continue
to remain different, as the Codex MRL is for the parent compound only.
C. Revisions to Petitioned-For Tolerances
Although the petitioner sought tolerances for many of the
commodities in Crop Groups 15 and 16, the petitioner did not request
crop group tolerances. EPA has determined that a tolerance for either
Crop Group 15 or Crop Group 16 commodities is not appropriate except
for Crop Group 15 grains (except barley), because the use pattern is
not the same for all Crop Group 15 commodities. Specifically, there is
a foliar use on barley and there are much higher tolerances for barley
hay and straw associated with this foliar use. It is for similar
reasons that a Crop Group 16 tolerance would not be appropriate.
In addition, there are also significant differences in the
tolerances for the different cereal forages, i.e., wheat forage at 0.5
ppm, corn forage at 0.10 ppm, and sorghum forage at 0.02 ppm.
Therefore, tolerances for each individual commodity have been
established by translating residue data from the most appropriate
representative commodity, except for grains which all have the same
tolerance (excluding barley). Tolerances are not required for triticale
and wild rice because these commodities are covered by the wheat and
rice tolerances, as
[[Page 12739]]
specified in 40 CFR 180.1. Tolerances are also not needed for teosinte
forage and stover as these are not considered significant livestock
feed items and are not consumed by humans.
V. Conclusion
Therefore, tolerances are established for residues of thiamethoxam,
3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine and its metabolite, N-[(2-chloro-thiazol-5-
yl)methyl]-N '-methyl-N ''-nitro-guanidine, in or on barley, grain at
0.4 ppm; buckwheat, forage at 0.50 ppm; buckwheat, hay at 0.02 ppm;
buckwheat, straw at 0.02 ppm; grain, cereal, group 15, except barley at
0.02 ppm; oat, forage at 0.50 ppm, oat, hay at 0.02 ppm; oat, straw at
0.02 ppm; millet, pearl, forage at 0.02 ppm; millet, pearl, stover at
0.02 ppm; millet, proso, forage at 0.02 ppm; millet, proso, stover at
0.02 ppm; millet, proso, straw at 0.02 ppm; rye, forage at 0.50 ppm;
rye, straw at 0.02 ppm. Tolerances are revoked for corn, field, grain;
corn, pop, grain; rice, grain; sorghum, grain; wheat, grain. These
tolerances are no longer needed, since residues on these commodities
will be covered by the crop group 15 tolerances being established in
this rule.
In addition, administrative corrections are being made to the
existing tolerances for grain, aspirated fractions and soybean, hulls,
as follows: The tolerance for grain, aspirated fractions at 0.08 ppm is
being corrected to grain, aspirated fractions at 2.0 ppm; the tolerance
for soybean, hulls at 2.0 ppm is being corrected to soybean, hulls at
0.08 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 17, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.565 paragraph (a) is revised to read as follows:
Sec. 180.565 Thiamethoxam; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide thiamethoxam, including its metabolites and degradates, in
or on the following commodities. Compliance with the tolerance levels
specified below is to be determined by measuring only thiamethoxam 3-
[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-
oxadiazin-4-imine and its metabolite CGA-322704 N-[(2-chloro-thiazol-5-
yl)methyl]-N'-methyl-N''-nitro-guanidine, calculated as the
stoichiometric equivalent of thiamethoxam, in or on the following
commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Alfalfa, forage........................................... 0.05
Alfalfa, hay.............................................. 0.12
Almond, hulls............................................. 1.2
Artichoke, globe.......................................... 0.45
Avocado................................................... 0.40
Barley, grain............................................. 0.4
Barley, hay............................................... 0.40
Barley, straw............................................. 0.40
Bean, succulent........................................... 0.02
Berry, low growing, subgroup 13-07G, except cranberry..... 0.30
Borage, seed.............................................. 0.02
Brassica, head and stem, subgroup 5-A..................... 4.5
Brassica, leafy greens, subgroup 5-B...................... 3.0
Buckwheat, forage......................................... 0.50
Buckwheat, hay............................................ 0.02
Buckwheat, straw.......................................... 0.02
Bushberry subgroup 13-07B, except lingonberry and 0.20
blueberry, lowbush.......................................
Canistel.................................................. 0.40
Canola, seed.............................................. 0.02
Cattle, meat.............................................. 0.02
[[Page 12740]]
Cattle, meat byproducts................................... 0.04
Citrus, dried pulp........................................ 0.60
Coffee, bean, green \1\................................... 0.05
Corn, field, forage....................................... 0.10
Corn, field, stover....................................... 0.05
Corn, pop, forage......................................... 0.10
Corn, pop, stover......................................... 0.05
Corn, sweet, forage....................................... 0.10
Corn, sweet, kernel plus cob with husks removed........... 0.02
Corn, sweet, stover....................................... 0.05
Cotton, gin byproducts.................................... 1.5
Cotton, undelinted seed................................... 0.10
Crambe, seed.............................................. 0.02
Cranberry................................................. 0.02
Flax, seed................................................ 0.02
Food commodities and feed commodities (other than those 0.02
covered by a higher tolerance as a result of use on
growing crops) in food/feed handling establishments......
Fruit, citrus, group 10................................... 0.40
Fruit, pome, group 11..................................... 0.2
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy 0.20
kiwifruit................................................
Fruit, stone, group 12.................................... 0.5
Goat, meat................................................ 0.02
Goat, meat byproducts..................................... 0.04
Grain, aspirated fractions................................ 2.0
Grain, cereal, group 15, except barley.................... 0.02
Grape, raisin............................................. 0.30
Hog, meat................................................. 0.02
Hog, meat byproducts...................................... 0.02
Hop, dried cones.......................................... 0.10
Horse, meat............................................... 0.02
Horse, meat byproducts.................................... 0.04
Mango..................................................... 0.40
Milk...................................................... 0.02
Millet, pearl, forage..................................... 0.02
Millet, pearl, stover..................................... 0.02
Millet, proso, forage..................................... 0.02
Millet, proso, stover..................................... 0.02
Millet, proso, straw...................................... 0.02
Oat, forage............................................... 0.50
Oat, hay.................................................. 0.02
Oat, straw................................................ 0.02
Peanut.................................................... 0.05
Peanut, hay............................................... 0.25
Peanut, meal.............................................. 0.15
Peppermint, tops.......................................... 1.5
Pistachio................................................. 0.02
Potato.................................................... 0.25
Radish, tops.............................................. 0.80
Rapeseed, seed............................................ 0.02
Rye, forage............................................... 0.50
Rye, straw................................................ 0.02
Sapodilla................................................. 0.40
Sapote, black............................................. 0.40
Sapote, mamey............................................. 0.40
Sheep, meat............................................... 0.02
Sheep, meat byproducts.................................... 0.04
Sorghum, forage........................................... 0.02
Sorghum, grain, stover.................................... 0.02
Soybean, hulls............................................ 0.08
Spearmint, tops........................................... 1.5
Star apple................................................ 0.40
Sunflower................................................. 0.02
Tomato, paste............................................. 0.80
Vegetable, cucurbit, group 9.............................. 0.2
Vegetable, fruiting, group 8.............................. 0.25
Vegetable, leafy, except brassica, group 4................ 4.0
Vegetable, legume, group 6................................ 0.02
Vegetable, root, subgroup 1A.............................. 0.05
Vegetable, tuberous and corm, except potato, subgroup 1D.. 0.02
Wheat, forage............................................. 0.50
Wheat, hay................................................ 0.02
Wheat, straw.............................................. 0.02
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of September 17, 2003.
* * * * *
[FR Doc. 2012-4983 Filed 3-1-12; 8:45 am]
BILLING CODE 6560-50-P